18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00363402
First received: August 10, 2006
Last updated: May 19, 2009
Last verified: August 2006

August 10, 2006
May 19, 2009
August 2006
August 2007   (final data collection date for primary outcome measure)
  • Improved diagnosis of CF patients
  • Real-time follow up of treatment
Same as current
Complete list of historical versions of study NCT00363402 on ClinicalTrials.gov Archive Site
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18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF)
18FDG- PET/CT Contribution to the Assessment of Lesion Severity in Cystic Fibrosis (CF

Cystic fibrosis (CF) is an autosomal recessive disorder caused by mutations in the CF trans-membrane conductance regulator (CFTR) protein. CF is the most common inherited disease of Caucasians, with a carrier frequency of 1 in 25-30 individuals. Even with the impressive advances achieved in the understanding of the molecular basis and physiopathology of CF, it remains a life-threatening disorder that causes severe lung damage and nutritional deficiencies. It is generally accepted that early therapy could delay the progression of lung disease. A number of non-invasive methods are available to monitor disease activity in CF patients; however none of the currently used tools are able to monitor real-time events. Recently high resolution computed tomography (HRCT) has been used to monitor changes in lung structure. However, HRCT does not allow differentiating between acute and chronic lesions. Positron emission tomography (PET) with 18fluoro-deoxy-glucose (FDG) has already been used in a variety of settings to visualize inflammation or infection. FDG-PET imaging appears to be a promising new tool to quantify inflammation as it can detect clinically relevant changes even when no changes or minimal ones are detected by morphologic imaging. PET/CT may consequently be used to evaluate the severity of lung inflammation/infection in CF patients, and therefore the aim of this study is to evaluate the use of PET/CT for the assessment of the severity of lung inflammation/ infection in CF patients.

Cystic fibrosis patients with active lung disease will undergo a high resolution PET-CT.PET/CT scans (GE ST Discovery PET/CT scanner) will be performed 60 to 90 minutes after injection of 5 MBq/kg of FDG. PET/CT will be repeated at the end of the treatment and compared with the results of the initial scan. PET and CT will be interpreted by a certified nuclear medicine physician and by a certified radiologist, respectively, blinded to clinical data, using the PET severity score (PSS), based on the number and the intensity of FDG uptake of lung foci. Intensity of uptake will be determined by calculating the mean value for the maximum standardized uptake values (MSUV) of all foci.

(SUV = Activity concentration in ROI (region of interest) divided by injected dose / patient body weight). SUV will be measured in normal lungs to receive the normal baseline control for the calculations. The correlation with clinical data (FEV1% predicted) and sputum bacteriology will then be performed. Inflammation status will also be followed by cytokine analysis.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Cystic Fibrosis
Procedure: PET-CT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:CF patients with active lesions in their lungs -

Exclusion Criteria:pregnancy,

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Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00363402
PETCT-HMO-CTIL
Not Provided
Arik Tzukert, DMD, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Study Director: Eitan Kerem, MD Hadassah Medical Organization
Hadassah Medical Organization
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP